Flashcards in Clinical Trials Deck (10):
Determines toxicity + establish maximum tolerated dose
Dose escalation is performed, starting at 10% of dose that is lethal in 10% of mice (LD10)
Phase 1 pt requirements
Any tumour with no conventional therapy available
Pts must be fit + have normal hepatic + renal function
Assesses particular anti-tumour activity in range of cancer
Measures response rate
Not necessary but useful to have a control arm + random allocation for treatment
Randomised trials comparing new + established treatments
Assesses overall survival + progression free survival
What are response end points?
Tumour growth/ shrinkage
Quality of life
What is RECIST?
Response Evaluation Criteria in Solid Tumours
complete or partial response, progression or stable disease
What statistical issues are involved with clinical trials?
Randomisation - reduces bias. Can be blinded or double blinded
Number of patients - to demonstrate a small effect at high significance, large cohort needed
Survival curves - data is presented graphically as a Kaplan Meier curve
What is a basket trial?
Tumours harbouring genetic mutations are tested with new drug that targets mutation
What is an umbrella trial?
Patients with particular type of cancer are tested to establish genetics of tumours + then offered different experimental treatments based on results